Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of licefreee spray against nix 1% permethrin

Conditions: Pediculosis Capitis

Summary: the purpose of this study is to evaluate the safety and efficacy of licefreee spray in eradicating head lice as compared to nix, both are available over-the-counter lice treatments.

head lice is a worldwide problem. many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.

Eligibility criteria:
inclusion criteria: * must be 4 years of age or older * must have an active head lice infestation of at least 10 lice and viable nits * agree not used any other pediculicides or medicated products during the study * agree not to use a nit comb during the study * must have a single place of residence exclusion criteria: * used any form of head lice treatment, prescription, otc or home remedy for at least four weeks prior to their visit * used topical medication of any kind on the hair for a period of 48 hours prior to visit * individuals receiving systemic, topical drugs or medications which may interfere with the study results * has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products * individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation * females who are pregnant or nursing
a study of ly3381916 alone or in combination with ly3300054 in participants with solid tumors

Conditions: Solid Tumor; Non Small Cell Lung Cancer; Renal Cell Carcinoma; Triple Negative Breast Cancer

Summary: the purpose of this study is to evaluate the safety of the study drug ly3381916 administered alone or in combination with anti-programmed cell death ligand 1 (pd-l1) checkpoint antibody (ly3300054).


Eligibility criteria:
inclusion criteria: * dose escalation phase: participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. * dose expansion b1: metastatic tnbc participants who have not received prior pd-1/l1 treatment. * dose expansion b2: metastatic nsclc participants who have progressed on prior pd-l1/l1 treatment. * dose expansion b3: metastatic clear cell carcinoma rcc who have progressed on prior pd-l1/l1 treatment. * have adequate organ function. * have a performance status (ps) of ≤1 on the eastern cooperative oncology group (ecog) scale. * are able and willing to provide required, newly acquired tumor biopsies. * have discontinued previous treatments for cancer. * are able to swallow capsules. exclusion criteria: * currently enrolled in a clinical study. * have known symptomatic central nervous system metastases or carcinomatous meningitis. * have a serious concomitant systemic disorder. * have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis b or c. * have a significant cardiac condition. * have previously received an indoleamine- 2,3-dioxygenase (ido) inhibitor. * have an active autoimmune disease or currently require immunosuppression of \>10 milligrams of prednisone or equivalent per day. * have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.

Keywords: ido-1 inhibitor ido1 inhibitor ido inhibitor
intradermal needle therapy for major depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is a common mental disorder that affects patients' physical health and quality of life. although traditional acupuncture therapy has certain advantages in improving mdd, there are still some limitations, such as being time-consuming and some people having a fear of acupuncture. therefore, intradermal needle therapy will be chosen in the treatment of mdd in this study, which is more convenient, shallow needling, and gentle than traditional acupuncture therapy. the study is designed to investigate the therapeutic effect and safety of intradermal needles for mdd.

a total of 120 participants with mdd who meet the inclusion criteria will be included in the study. participants will be randomly divided into the ssris + acupuncture group, acupuncture + placebo group, and ssris + sham acupuncture group. this study will evaluate the efficacy and safety of the intradermal needle for mdd and investigate whether the intradermal needle reduces side effects and increases the efficacy of selective serotonin reuptake inhibitors (ssris) antidepressants for mdd. furthermore, the study will demonstrate whether the intradermal needle has a synergistic effect with ssris on the treatment of mdd.

Eligibility criteria:
inclusion criteria: * 1. patients should meet the diagnostic criteria of the international classification of diseases 10th edition (icd-10) diagnostic criteria for depression and are evaluated as moderate or severe mdd according to the severity of depression; 2. 12 ≤ age ≤60, male or female; 3. participants have clear consciousness and could communicate with others normally; 4. participants could understand the full study protocol and have high adherence. written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them). exclusion criteria: * 1. participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; 2. major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; 3. participants with suicidal tendencies; 4. pregnant or lactating participants; 5. participants taking other antidepressants that were not ssris or the pharmacological effects of such antidepressants have not been cleared; 6. participants with intellectual disabilities who cannot cooperate with the questionnaire survey; 7. participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; 8. participants are participating in other trials.

Keywords: major depressive disorder acupuncture randomized controlled clinical trial
investigation of the efficacy and safety of incobotulinumtoxina (xeomin) in parkinson's tremor: a customized approach

Conditions: Parkinson; Tremor

Summary: the scientific aim of this study is to investigate the efficacy and safety of incobotulinumtoxina (xeomin-merz pharmaceuticals) in the tremor of parkinson"s disease. our hypothesis is that injection of xeomin into the muscles of arm, forearm and hand decreases the tremor amplitude and frequency leading to improvement of the patient"s function.

this is an investigator initiated, randomized, double blind, placebo controlled, cross over study which is supported by merz pharmaceuticals. patients with parkinson"s disease (at yale neurology and movement disorders clinics) will be approached by the members of the research team (pi and sub-investigators) to see if they meet inclusion and exclusion criteria and wish to participate in the study. if eligible and consented to participate in the study, there will be a series of questionaires, examinations and treatment sessions.

Eligibility criteria:
inclusion criteria. 1. age more than 18 years 2. both sexes 3. all races/ethnic groups. 4. meeting the clinical diagnosis of parkinson's disease with presence of moderate to severe parkinson tremor that is refractory to standard medical treatments and which limits the patient"s functionality and/or poses significant discomfort. 5. subjects who are able to read, speak, and understand english. exclusion criteria. 1. existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders) or significant swallowing or breathing difficulties. 2. pregnancy or planned pregnancy (determined by urine pregnancy test). 3. active breast feeding. 4. enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol. 5. any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication. 6. subjects who are younger than 18 years of age. neuromuscular-junction disorders. 7. evidence of acute pathology in neuro-imaging. 8. axis i diagnosis determined by a neurologist or psychiatrist. 9. use of anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment. 10. those who received botulinum toxin injections in the past 4 months.

Keywords: tremor parkinson botulinum xeomin
effect of an exercise on serum uncoupling protein-1 level and the role of uncoupling protein-1-3826 a/g polymorphism

Conditions: Uncoupling Protein-1; Polymorphism, Restriction Fragment Length; Irisin

Summary: this study aims to determine the effect of an acute maximal exercise on serum uncoupling protein-1, irisin, interleukin 6 levels, and on blood lipid and lipoprotein concentrations. this study also evaluates the role of uncoupling protein-1-3826 a/g polymorphism on this eventual effect. therefore, this study hypothesizes that: h01: sedentary people and athletes' serum uncoupling protein 1, irisin, and interleukine 6 levels are different before and after an acute maximal exercise. h02: sedentary people and athletes' basal serum uncoupling protein 1 levels are associated with uncoupling protein 1-3826 a/g polymorphism. h03: uncoupling protein 1-3826 a/g polymorphism has a modifying role in the effect of maximal exercise on serum uncoupling protein 1 levels. h04: sedentary people and athletes' basal serum lipid and lipoprotein levels are associated with uncoupling protein 1-3826 a/g polymorphism. h05: uncoupling protein 1-3826 a / g polymorphism has a modifying role in the effect of maximal exercise on serum lipid and lipoprotein levels.


Eligibility criteria:
inclusion criteria: * athletes group: * must be basketball, or volleyball, or handball players. * must be subjects who have been training regularly for at least 3 months. * sedentary group: \* must be subjects who have not been training regularly for at least 3 months. * for both groups: * healthy. * non obese (body mass index \< 30). * aged between 18 and 35 years. exclusion criteria: * for both groups: * being regular consumer of cigarettes, alcohol, drugs and antioxidant substances. * being obese (body mass index \> 30). * having an acute or chronic injury which is limiting physical performance. * having a disease (anemia, infection...) detected from the biochemical analysis of the blood samples. * being injured or sick during the study.

Keywords: beige fat cell fat tissue athletes sedentary people irisin
effect of metformin and cholecystokinin-mediated gallbladder emptying on glp-1 secretion in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: accumulating evidence suggests that bile acids in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion and consequently affect glucose homeostasis. the current study is a human interventional randomized controlled cross-over study including four study days for each participant. metformin will be applied as a tool to reduce bile acid reuptake in the small intestine; thereby increasing bile acid concentration in the more distal parts of the gut where glp-1-secreting l cell are abundant. interestingly, metformin has been shown to reduce the active reabsorption of bile acids in the ileum and cause increased faecal elimination of bile acids. clinical data has suggested that metformin causes an increase in the postprandial secretion of glp-1 in humans including patients with type 2 diabetes. intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. the aim is to examine how (and if) modification of bile acid reabsorption can influence postprandial glucagon-like peptide-1 (glp-1) secretion and glucose homeostasis in patients with type 2 diabetes. the investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. the current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 3 months (diagnosed according to the criteria of the world health organization (who)) * men and postmenopausal women * metformin applied as the only anti-diabetic drug * caucasian ethnicity * normal haemoglobin * bmi \>23 kg/m2 and \<35 kg/m2 * informed and written consent exclusion criteria: * liver disease (alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary disorder * gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * nephropathy (serum creatinine \>150 µm and/or albuminuria) * hypo- and hyperthyroidism * hypo- and hypercalcaemia * hypo- and hyperphosphataemia * active or recent malignant disease * treatment with medicine that cannot be paused for 12 hours * treatment with oral anticoagulants * any treatment or condition requiring acute or sub-acute medical or surgical intervention * any condition considered incompatible with participation by the investigators
the effectiveness of waiting room posters for stroke education

Conditions: Stroke, Acute

Summary: the purpose of this study is to determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. the control group study will be conducted in the first two weeks. subsequently, the intervention arm will occur in the subsequent two weeks.

stroke is a major health problem and a known cause of death and disability worldwide. in malaysia, stroke is known to be top five causes of death and top ten causes of hospitalization malaysia. ischemic stroke accounts for more than 95% of all stroke cases (1). a recent study done in malaysia showed that only 26% of patients with stroke symptoms presented to the hospital within 3 hours. one of the reasons was patients did not perceive the symptoms of stroke as being that of a serious illness (2). one of the modalities to raise awareness of stroke is through an educational poster. posters in the waiting room can increase awareness of health promotion issues (3). therefore, by placing poster regarding sign and symptoms of stroke in the waiting room in a government clinic, can increase awareness of early presentation of stroke.

Eligibility criteria:
inclusion criteria: * adult age more than 18 years old and above * able to understand malay * able to provide informed consent exclusion criteria: * none

Keywords: awareness poster stroke
surveillance for new lung primaries

Conditions: Lung Cancer

Summary: this clinical research protocol proposes to perform low dose helical computed tomographic (ct) scanning in 250 high-risk patients (125/year for two years) in order to detect lung carcinomas when they are small and subject to effective curative therapies.


Eligibility criteria:
inclusion criteria: * asymptomatic exclusion criteria: * 20 pack year history

Keywords: surveillance for lung cancer
a study to assess the safety and tolerability of zx008 in children and young adults with dravet syndrome or lennox gastaut syndrome currently taking cannabidiol

Conditions: Dravet Syndrome; Lennox Gastaut Syndrome

Summary: this is an open label study to evaluate the safety of zx008 (fenfluramine) in patients with dravet syndrome (ds) or lennox gastaut syndrome (lgs) who are being administered cannabidiol (cbd).


Eligibility criteria:
key inclusion criteria: * subject has a clinical diagnosis of ds or lgs, where convulsive seizures (generalized tonic clonic seizures, tonic seizures, atonic seizures, tonic/atonic seizures, focal seizures with clear observable motor signs) are not completely controlled by current aeds. * all medications or interventions for epilepsy (including ketogenic diet \[kd\] and vagal nerve stimulation \[vns\]) must be stable for at least 4 weeks prior to first zx008 dose and are expected to remain stable throughout the study. * subjects must be taking a stable dose of cbd for at least 4 weeks prior to first zx008 dose. * subject's source of cbd is expected to be consistent for at least 3 months during study participation. key exclusion criteria: * subject has current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke. * subject with current cardiac valvulopathy or pulmonary hypertension that the investigator, parent/caregiver, independent cardiac advisory board, independent data and safety monitoring committee, or sponsor deems clinically significant. * subject has a current or past history of glaucoma.

Keywords: dravet syndrome lgs
rtms for depression

Conditions: Depression

Summary: this is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of fda approved right dlpfc rtms treatment.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 to 80 years of age 2. dsm v diagnosis of a major depressive episode subjects must have an initial score of at least 20 on the hamd at screen 3. rtms is clinically indicated 4. patient is competent to provide informed consent exclusion criteria: 1. lifetime dsm-v diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the dsm-v 2. current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression and is the primary diagnosis 3. current diagnosis of delirium, dementia, or amnestic amnesiac disorder 4. diagnosis of mental retardation 5. baseline mini mental state exam (mmse) score \< 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less 6. any active general medical condition or cns disease which can affect cognition or response to treatment 7. current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report. 8. ect or rtms within three months 9. pregnancy as indicated by self-report 10. mri contraindications 11. implanted electronic device or metal implant in the head and neck region (dbs, cochlear implant, etc) 12. change in the dose of psychotropic medications within the past week inclusion criteria for healthy volunteers: 1. male or female between age 18 and 80 2. patient is competent to provide informed consent exclusion criteria for healthy volunteers: 1. lifetime history of major chronic mental illness, such as schizophrenia, major depression, or bipolar disorder 2. lifetime history of psychiatric hospitalization because of any mental illness mental illness, other than depression, that needed psychological or pharmacological treatment in the past 3. any neurodevelopmental or neurodegenerative disease, or stroke or positive findings on past head ct or brain mri 4. pregnancy 5. hamilton rating scale for depression (hrsd-17) is more than 7 6. mri contraindications
safety and efficacy of multiple doses of qax028 in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will assess the bronchodilator effects of multiple doses of qax028 at two different dose levels when compared to tiotropium and placebo in a copd population.


Eligibility criteria:
inclusion criteria: * diagnosis of copd according to gold guidelines * post-bronchodilator 30%≤fev1\<80% of predicted normal and ost-bronchodilator fev1/fvc \<0.7 * smoking history of at least 10 pack years exclusion criteria: * requiring oxygen therapy on a daily basis * exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing * lung reduction surgery * respiratory tract infection in the 6 weeks prior to screening * significant cardiac history * history of asthma with onset of symptoms prior to age 40 years * active use of certain copd medications, beta blockers other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd long acting muscarinic antagonist
effects of rimonabant on walking abilities in incomplete spinal cord injury

Conditions: Spinal Cord Injuries

Summary: randomized placebo-controlled safety and feasibility study with crossover design (3 arms). placebo or rimonabant 2.5mg or rimonabant 5mg will be administered for 5 days. exploratory efficacy will be tested using six-min walking test.

randomized placebo-controlled safety and feasibility study with crossover design (3 arms). placebo or rimonabant 2.5mg or rimonabant 5mg will be administered for 5 days. exploratory efficacy will be tested using six-min walking test. main goal is to test safety of rimonabant in a specific population (incomplete spinal cord injury).

Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury * incomplete lesion (ais d) * neurological level between c4 and l1 * chronic stage (\>1 year since injury) * preserved walking ability for at least 5 m (aid allowed) * psychiatric assessment to exclude individuals with high suicide risk * capability to provide informed consent * for fertile women, possibility to use anti conceptive methods exclusion criteria: * non traumatic spinal cord injury * ais a, b, c or e * neurological level above c4 or below l1 * subacute stage (\<1 year since injury) * preserved walking ability for less than 5 m (aid allowed) * pregnancy or breast feeding * for fertile women, impossibility to use anti conceptive methods * anticoagulant treatment * hypothyroidism * severe kidney or liver dysfunction * severe depression * fatigue treatment in the last 6 months * impossibility to reach the hospital * impossibility to provide informed consent

Keywords: spinal cord injury walking endurance incomplete sci traumatic
a study of ym060 in diarrhea-predominant irritable bowel syndrome (d-ibs)

Conditions: Irritable Bowel Syndrome

Summary: this study will examine the efficacy, safety and tolerability of different oral dose of ym060, 5-ht3 receptor antagonist, in patients with d-ibs.


Eligibility criteria:
inclusion criteria: * patient meets rome ii criteria for ibs and the subgroup of diarrhea predominant ibs exclusion criteria: * patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding ibs), blood diseases, or neurological or psychiatric diseases * patient reported having any type 1 or type 2 stool on the bristol stool form scale during the run-in period

Keywords: irritable bowel syndrome diarrhea nasea® irribow® ramosetron